[The National Vaccine Advisory Committee (NVAC) Charter is renewed every two years in accordance with Federal advisory committee guidelines. The current charter expires July 30, 2021.]
National Vaccine Advisory Committee
Section 2105 of the Public Health Service (PHS) Act, as amended (42 U.S.C. Section 300aa-5). The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of advisory committees.
Objectives and Scope of Activities
The Secretary of Health and Human Services is mandated under Section 2101 of the PHS Act (42 U.S.C. Section 300aa-1) to establish a National Vaccine Program (NVP) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. Pursuant to the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, the Assistant Secretary for Health (ASH) shall serve as Director of the NVP (42 FR 61318, dated Dec. 2, 1977; as amended in 52 FR 23502, dated June 22, 1987) and shall provide advice and counsel on public health and science issues to the Secretary (60 FR 56606-06, dated Nov. 9, 1995). The National Vaccine Advisory Committee (NVAC or the Committee) shall advise and make recommendations to the Director of the NVP on matters related to the Program’s responsibilities.
Description of Duties
The functions of the Committee as stated in Section 2105 of the Public Health Service (PHS) Act are as follows:
- Study and recommend ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States.
- Recommend research priorities and other measures the Director of the NVP should take to enhance the safety and efficacy of vaccines.
- Advise the Director of the NVP in the implementation of Sections 2102 and 2103 of the PHS Act. (42 U.S.C. Secs. 300aa-2 and 300aa-3)
- Identify annually for the Director of the NVP the most important areas of governmental and non-governmental cooperation that should be considered in implementing Sections 2101 and 2103 of the PHS Act. (42 U.S.C. Secs 300aa-2 and 300aa-3)
Official to Whom the Committee Reports
As stipulated in the authorizing legislation, under Section 2105 of the Public Health Service Act, the Committee reports to the Director of the NVP. The Assistant Secretary for Health has been assigned by the Secretary to serve as Director of the NVP.
Management and support services for Committee activities are provided by the Office of Infectious Disease and HIV/AIDS Policy (OIDP), an office within the Office of the Assistant Secretary for Health (OASH). OASH is a staff division in the Office of the Secretary of the Department of Health and Human Services.
Estimated Annual Operating Costs and Staff Years
The estimated annual cost for operating the Committee, including compensation and travel expenses for members, but excluding staff support, is $160,000. The estimate of annual person-years of staff support required is 3.3, at an estimated cost of $280,225.
Designated Federal Officer (DFO)
A senior level staff of the OIDP may be appointed by the Director of the NVP to serve as the Designated Federal Officer (DFO) for the Committee. The Director of the NVP will select a qualified staff person from among full-time or permanent part-time staff within OIDP to carry out the associated duties. In the event that the designated official cannot fulfill the assigned responsibilities for the Committee, then the Director of the NVP or designee shall select another qualified permanent full-time or part-time senior level staff person from among staff within the OASH to permanently and/or temporarily carry out the assigned duties.
The DFO will schedule and approve for all meetings of the parent Committee and respective subcommittees to be held. The DFO will prepare and approve all meeting agendas; development of the meeting agenda can be done in collaboration with the Committee Chair. The DFO or other official to whom the authority has been delegated will be present at all meetings of the full Committee and any subcommittees/working groups that have been assembled to assist the Committee. The DFO has authority to adjourn meetings, when it is determined to be in the public interest, and may also chair the Committee meetings when directed to do so by the Director of the NVP or designee.
Estimated Number and Frequency of Meetings
Meetings will be held, at a minimum, three times per year; approximately every four months. A quorum for the conduct of business by the full Committee shall consist of a majority of the Committee’s voting members. Meetings shall be open to the public except as determined otherwise by the Secretary, or other official to whom the authority has been delegated, in accordance with guidelines under Government in the Sunshine Act at 5 U.S.C. 552b(c) and the Federal Advisory Committee Act. Notice of all meetings is provided to the public 15 calendar days prior to the meeting. Meetings will be conducted and records of the proceedings will be kept, as required by applicable laws and Departmental policies.
When it is determined by the Secretary or designee that a meeting will be closed or partially closed to the public, in accordance with stipulations of Government in the Sunshine Act, 5 U.S.C. 552b(c), then a report will be prepared that includes, at a minimum, a list of the members and their business addresses, the Committee’s functions, date and place of the meeting, and a summary of the Committee’s activities and recommendations made during the fiscal year. A copy of the report will be provided to the Department Committee Management Officer.
The National Vaccine Advisory Committee is statutorily mandated; no specific end date has been established.
Unless renewed by appropriate action, the charter for the Committee will be terminated two years from the date it is filed.
Membership and Designation
The Committee consists of 17 voting members. The Committee structure is composed of 15 individuals, including the Chair, who are appointed to serve as public members and two individuals who are designated to serve as official representatives of the vaccine manufacturing industry. The public members are selected from individuals who are engaged in vaccine research or the manufacture of vaccines, or who are physicians, members of parent organizations concerned with immunizations, representatives of State or local health agencies or public health organizations. The public members are voting members and classified as special government employees (SGEs). Committee members are appointed by the Director of the NVP, in consultation with the National Academy of Sciences; affected entities of the vaccine industry will be consulted, as well, for selection of the two representative members.
The Committee membership may also consist of representatives from appropriate federal agencies and non-federal entities, including state and local health agencies or public health organizations that are engaged in and/or have interest in vaccine research, the manufacture of vaccines, and immunizations. Individuals who are appointed to represent federal organizations will serve as ex-officio, nonvoting members. The federal ex-officio members are regular government employees who may attend Committee meetings and share information at such meetings to inform the Committee in generating recommendations with respect to the Committee's functions under Section 2105 of the PHS Act. Individuals who are appointed to represent non-federal entities will serve as non-voting liaison representatives. The Director of the NVP or designee will extend an invitation of membership to the federal and non-federal entities and/or interest groups as it is deemed necessary to accomplish the established mission of the Committee.
Voting members are invited to serve for overlapping terms of up to four years, except any member appointed to fill the vacancy of an unexpired term will be appointed to serve for the remainder of that term. Terms of more than two years are contingent upon renewal of the Committee by appropriate action prior to its termination. A member may serve after the expiration of their term until their successor has taken office, but no longer than 180 days.
The Chair shall be appointed for a three year term unless otherwise specified. The Chair will be chosen from among persons who preferably have had at least one year experience as a voting member and, preferably, have demonstrated ability both to lead the work of similar bodies and to work effectively in partnership with federal agencies and partner organizations.
The voting members of the parent Committee shall be paid per diem and travel expenses, as authorized by Section 5703, Title 5 U.S.C., as amended for persons employed intermittently in the Government service. The public voting members shall serve on the Committee without any other compensation, pursuant to an advance written agreement. Individuals who are appointed to serve as official representative members of the vaccine manufacturing industry or any particular interest group or business sector will serve without compensation. The representative members may be allowed per diem and any applicable expenses for all travel performed that is related to conducting business for the Committee.
In carrying out its functions, the Committee may establish subcommittees composed of members of the parent Committee, as well as other individuals (e.g., individuals from organizations and the public at-large who are concerned and knowledgeable about immunizations and other topics pertaining to the NVAC mission), with approval and/or recommendation of the Director of the NVP or designee. The Department Committee Management Officer will be notified upon establishment of each subcommittee, and will be provided information on its name, membership, function, and estimated frequency of meetings. All reports and recommendations of the subcommittee must be reported back to the full Committee for deliberation by the full Committee. No recommendation or report of the subcommittee can be given directly to the Director of the NVP without first being provided to the full Committee for discussion.
Records of the Committee and any established subcommittees will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records or other approved agency records disposition schedule. Applicable records will be made available to the public for inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
Filing Date: July 30, 2019
|7/25/2019||_____/Admiral Brett P. Giroir, M.D./|
|Date||Assistant Secretary for Health
and Director, National Vaccine Program
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